Skip to content

IMProving Adherence to Colonoscopy Through Teams and Technology

IMProving Adherence to Colonoscopy Through Teams and Technology

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06191185
Acronym
IMPACTT
Enrollment
2000
Registered
2024-01-05
Start date
2024-07-08
Completion date
2027-03-01
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Colorectal, Colon Cancer, Colorectal Cancer

Brief summary

Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. The proposal will implement multi-level approach consisting of a stepped-wedge clinic-level intervention of team-based best practices co-developed with primary and specialty care, a patient-level technology intervention to provide enhanced instructions and navigation to complete diagnostic colonoscopy, and a mixed methods evaluation to explore multi-level factors contributing to intervention outcomes. Developing a solution to this high-risk and diverse population has the potential to translate to other health systems, support patient self-management, and address other patient conditions.

Detailed description

Follow-up colonoscopy after abnormal stool-based colorectal cancer screening (e.g., fecal immunochemical test (FIT)) results in early detection of colorectal cancer (CRC), prevention of CRC, and reduction in CRC mortality. FIT is a commonly utilized screening test that can be performed at home, is inexpensive, scalable, and often adopted in health systems where colonoscopy resources are scarce. Despite evidence that timely colonoscopy is necessary after an abnormal FIT result, completion of colonoscopy occurs in less than 50% of patients at 6 months and varies significantly by clinic and health systems. In addition to understanding the meaning of an abnormal FIT, three care transitions must occur smoothly for the patient: colonoscopy referral, scheduling, and attendance. However, multilevel factors influence missed follow-up, and multilevel solutions are needed along the care continuum to address clinic-, provider-, and patient-level factors that impair or delay colonoscopy completion. IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT), proposes to close gaps and reduce disparities in CRC screening by improving the completion of diagnostic colonoscopy following abnormal FIT in vulnerable populations using a multilevel approach consisting of interventions at the clinic-, provider- and patient-level. The specific aims are 1) to evaluate the effect of a clinic-level intervention targeting primary care providers and staff to adopt "best practices" to support colonoscopy completion in patients with abnormal FIT results, 2) to determine the effect of a patient-level technology intervention with enhanced instructions and navigation for patients with abnormal FIT to complete a diagnostic colonoscopy, and 3) to explore the multilevel implementation factors contributing to intervention outcomes using mixed methods.

Interventions

BEHAVIORALBPB, No PIN

Patient-level: standard communication from care team. Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.

BEHAVIORALBPB, PIN

Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the short messaging service (SMS) text messaging platform, HealthySMS. Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.

BEHAVIORALNo BPB, PIN

Patient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the SMS text messaging platform, HealthySMS.

BEHAVIORALNo BPB, No PIN

Patient-level: standard communication from their care team.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients with abnormal FIT result * Patients ages 18 years or older * English, Spanish, or Cantonese speaking

Exclusion criteria

* Patients with normal FIT result * Patients younger than age 18

Design outcomes

Primary

MeasureTime frameDescription
Colonoscopy completion6 months after abnormal FIT resultWait time for routine colonoscopy is often less than 6 weeks and less than 2 weeks if one is willing to take an afternoon appointment. Completion of colonoscopy will be captured by extracting pertinent colonoscopy elements

Secondary

MeasureTime frameDescription
Quality of bowel preparationAt time of colonoscopy procedureThe quality of procedure preparation is defined as excellent, good, fair, and poor.
Referred to GI for colonoscopy6 weeks after abnormal FIT resultAfter an abnormal FIT result, providers should review the test result, communicate with patients, and refer the patient to GI to complete a colonoscopy.
Scheduled by GI for colonoscopy8 weeks after GI referralAfter an abnormal FIT result, providers will refer patients. The electronic referral is reviewed by GI, who will call the patient to schedule the colonoscopy.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORUrmimala Sarkar, MD, MPH

University of California, San Francisco

PRINCIPAL_INVESTIGATORMa Somsouk, MD, MAS

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026